Traumatic Brain InjuryNCT03833375
Shared Decision Making to Improve Goals-of-Care Decisions for Families of Severe Acute Brain Injury Patients
A study testing Decision Aid in people with Traumatic Brain Injury and Ischemic Stroke, run by University of Massachusetts, Worcester at 2 sites in United States.
Trial summary
Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and disability in adults in the U.S. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Ischemic Stroke, Intracerebral Hemorrhage
- What is being tested?
- Decision Aid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Feb 2018to 9 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age; no upper age limit
- Documented health care proxy or legal next of kin of admitted SABI patient with traumatic brain injury, intracerebral hemorrhage or acute ischemic stroke.
- ≥3 days after insult ("stabilization period"); clinical team may ask study team to wait longer if clinically indicated
- SABI patient remains "critically ill" after 3 days defined as: either intubated and mechanically ventilated, or unable to swallow, needing feeding tube beyond hospital discharge (even if not intubated)
- Surrogate is physically present in ICU to receive decision aid and participate in planned family meeting in person (not over phone)
Who cannot join
- Devastating SABI near death
- Patient will be extubated and pass swallow evaluation (as deemed by clinical team)
- Surrogate is non-English speaking and no interpreter available to translate decision aid (no available validated, translated decision aid version)
- Surrogate is illiterate
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale Medical School/Yale New Haven Medical Center
New Haven, Connecticut, 06520
University of Massachusetts Medical School
Worcester, Massachusetts, 01655
About this study
Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and disability in adults in the U.S. Due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is the most common cause of death in SABI, but occurs at a highly variable rate (for example in Traumatic Brain Injury (TBI) 45-89%). Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. The investigators have developed a pilot DA for goals-of-care decisions for surrogates of SABI patients. This was developed through qualitative research using semi-structured interviews in surrogate decision makers of TBI patients and physicians. The investigators now propose to pilot-test a DA for surrogates of SABI patients in a feasibility trial.
Read the detailed description
Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and disability in adults in the U.S, accounting for more than 200,000 of the acute brain injury-related deaths in the U.S. annually. Patients with SABI are critically ill and most commonly require mechanical ventilation and supportive medical care with artificial nutrition to ensure survival. However, due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is by far the most common cause of death in SABI but occurs at a highly variable rate (for example in TBI 45-90%) at different trauma centers. Shared decision making is a collaborative process that enhances patients' and surrogates' understanding about prognosis, encourages them to actively weigh the risks and benefits of a treatment, and to match them to patient preferences, thereby decreasing decisional conflict and improving decision quality and health related outcomes. Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. No DA currently exists for goals-of-care decisions in SABI. Such a patient- and family-centered DA has the potential to improve decision-making for SABI patients by ensuring proxies receive consistent, evidence-based prognostication while also addressing patients' preferences and values. The investigators have developed a pilot DA for goals of care decisions by surrogates of SABI patients using qualitative research using semi-structured interviews in surrogate decision makers of TBI patients and physicians, followed by an iterative feedback process with feedback by surrogates, physicians, and other stakeholders (ICU nurses). The investigators now propose to pilot-test a DA for surrogates of SABI patients in a feasibility trial.
- Being tested
- Decision Aid
- Keywords
- TBI, stroke, ICH, AIS, decision aid, shared decision making, neurocritical care, SABI, surrogate
- Medical subject headings
- Brain Injuries, Traumatic, Ischemic Stroke, Cerebral Hemorrhage, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision AidOther
Shared-decision making tool
| Study group | Role | What they receive |
|---|---|---|
| Usual Care (n=20) | No intervention | Control: general information about TBI from Center for Disease Control (CDC)/about stroke/Intracerebral Hemorrhage (ICH) from American Heart/Stroke Association |
| Decision Aid (n=20) | Experimental | Paper Decision aid (share decision making tool) with worksheet for surrogates Receives: Other: Decision Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Consent rate
Measured: From date of approaching surrogate decision maker for consent until the date of the first documented goals-of-care family meeting, assessed up to 1 month after admission.
Participation
Proportion of participants who read decision aid and completed worksheet
Measured: 1-36 hours after family meeting
Retention
Number of participants who complete follow-up
Measured: 3 months
Secondary outcomes (14)
Clinician-surrogate concordance scale score
measures prognostic concordance between ICU clinicians and surrogates. Participants from both groups will independently estimate numerically a SABI patient's 6-month survival and return to independence. Concordance is calculated as the absolute value of the difference in prognosis between the surrogate and the clinician, and, therefore, can range from 0 (no concordance) to 100 (full concordance).
Measured: Baseline and 1-36 hours after family meeting
Decision Self-Efficacy Scale
is a validated scale that measures self-confidence in making an informed choice using a 5-point Likert scale ranging from 0 (not at all confident) to 4 (very confident).
Measured: 1-36 hours after family meeting
Decisional Conflict Scale
is a validated scale that measures the personal perception of choosing an option and factors contributing to choice uncertainty. It is a 16-item, 5-item Likert scale with sub-scores for uncertainty, feeling informed, values clarity, decision support and effective decision-making. It ranges from 0 (strongly agree) to 4 (strongly disagree).
Measured: 1-36 hours after family meeting
AIS/Intracerebral Hemorrhage (ICH)/Traumatic Brain Injury (TBI) knowledge test
Medical knowledge about the goals-of-care decision in SABI will be assessed using the medical knowledge test, which was adapted to 17 questions about goals-of-care and SABI, all of which are addressed in the decision aid. The % correct will be calculated.
Measured: Baseline and 1-36 hours after family meeting
Hospital Anxiety and Depression Scale (HADS)
is a 14-item, two-domain (depression, anxiety) instrument with reliability and validity among ICU surrogates, which is recommended by consensus guidelines for the prospective measurement of psychological distress among ICU surrogates. Each of the 14 questions are scored between 0 (not at all) and 3 (most of the time), and summed up for a total HADS score, which ranges from 0 to 42, with higher scores indicating worse symptoms. Total HADS 0-7 =normal, 8-10 borderline abnormal, 11-21=abnormal, indicating high anxiety and depression.
Measured: Baseline,1-36 hours after family meeting, and 3-months
Impact of Events Scale-revised
is a is a validated 15-item instrument, measuring post-traumatic stress disorder (PTSD) symptoms. Total score is the sum of all questions and ranges from 0 to 88, with higher scores indicating worse PTSD symptoms.
Measured: Baseline,1-36 hours after family meeting, and 3-months
Quality of Communications Scale
is a is a validated 17-item patient-centered instrument widely used in the ICU to assess surrogates' satisfaction of clinician communication about treatments and understanding treatment decisions. It ranges between 0 (poor) to 10 (absolutely perfect). Total score is the sum of all questions and ranges from 0 to 100, with higher scores indicating better communication.
Measured: 1-36 hours after family meeting
Patient-Perceived Centeredness of Care Scale
is a is a validated 14-item, 4-point Likert scale based test. Its version adapted to surrogates has shown responsiveness in a recent trial of a nurse-driven communication intervention for surrogates in the ICU. It ranges between 1 (very well) to 4 (not at all), and median score is calculated from all questions. Median scores range from 1 to 4, with lower scores indicating more patient- and family-centered care.
Measured: 1-36 hours after family meeting
Cumulative duration of the goals-of-care family meetings
Investigators will track the duration of each goals-of-care meeting. At the patient's ICU discharge, investigators will sum up the cumulative duration of all goals-of-care meetings [minutes].
Measured: 1-36 hours after family meeting
Total number of goals-of-care family meetings
Investigators will sum up the total number of goals-of-care meetings at the patient's ICU discharge.
Measured: 1-36 hours after family meeting
Patient's survival status
Investigators will record whether the patient is dead or alive.
Measured: 3-months after goals of care decision
Patient's Glasgow Outcome Scale
The Glasgow Outcome Score (GOS) is a validated 5-point scale given to traumatic brain injury or other brain injury patients at some point in their recovery. It is a very general assessment of the general functioning of the person who suffered a head injury or other neurological injury. It ranges from 1-5 (higher scores indicating better functional status): 1=death, 2=Vegetative State, 3=Severely Disabled (conscious but the patient requires others for daily support due to disability), 4=Moderately Disabled (the patient is independent but disabled), 5=Good Recovery (the patient has resumed most normal activities but may have minor residual problems).
Measured: 3-months after goals of care decision
Patient's modified Rankin Scale
is a validated scale that measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological disability. It ranges from 0 (no symptoms at all) to 6 (death).
Measured: 3-months after goals of care decision
Surrogate Decision Regret Scale
is a validated scale that measures distress or remorse after a health care decision with high internal consistency. It asks 5 questions and provides a 5-point Likert scale. It ranges between 1 (strongly agree) to 5 (strongly disagree).
Measured: 3-months after goals of care decision
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start11 Feb 2018
- Primary completion2 Dec 2019
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, usual-care-controlled feasibility trial comparing decision aid intervention prior to the goals-of-care family meeting to standard of care (no intervention prior to family meeting).
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, University of Florida, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Susanne Muehlschlegel, University of Massachusetts, Worcester
- Investigators
- Dr. Susanne Muehlschlegel, MD, MPH, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833375
- Sponsor's protocol ID
- H00004724/H00015764
- Other IDs
- 5K23HD080971
- Status last verified
- Jun 2020
- First submitted
- 4 Feb 2019
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Quinn T, Moskowitz J, Khan MW, Shutter L, Goldberg R, Col N, Mazor KM, Muehlschlegel S. What Families Need and Physicians Deliver: Contrasting Communication Preferences Between Surrogate Decision-Makers and Physicians During Outcome Prognostication in Critically Ill TBI Patients. Neurocrit Care. 2017 Oct;27(2):154-162. doi: 10.1007/s12028-017-0427-2.
PubMed 28685395Moskowitz J, Quinn T, Khan MW, Shutter L, Goldberg R, Col N, Mazor KM, Muehlschlegel S. Should We Use the IMPACT-Model for the Outcome Prognostication of TBI Patients? A Qualitative Study Assessing Physicians' Perceptions. MDM Policy Pract. 2018 Mar 26;3(1):2381468318757987. doi: 10.1177/2381468318757987. eCollection 2018 Jan-Jun.
PubMed 30288437Muehlschlegel S, Shutter L, Col N, Goldberg R. Decision Aids and Shared Decision-Making in Neurocritical Care: An Unmet Need in Our NeuroICUs. Neurocrit Care. 2015 Aug;23(1):127-30. doi: 10.1007/s12028-014-0097-2.
PubMed 25561435Cai X, Robinson J, Muehlschlegel S, White DB, Holloway RG, Sheth KN, Fraenkel L, Hwang DY. Patient Preferences and Surrogate Decision Making in Neuroscience Intensive Care Units. Neurocrit Care. 2015 Aug;23(1):131-41. doi: 10.1007/s12028-015-0149-2.
PubMed 25990137Muehlschlegel S, Goostrey K, Flahive J, Zhang Q, Pach JJ, Hwang DY. Pilot Randomized Clinical Trial of a Goals-of-Care Decision Aid for Surrogates of Patients With Severe Acute Brain Injury. Neurology. 2022 Oct 3;99(14):e1446-e1455. doi: 10.1212/WNL.0000000000200937.
PubMed 35853748
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shared Decision Making to Improve Goals-of-Care Decisions for Families of Severe Acute Brain Injury Patients
- ClinicalTrials.gov ID
- NCT03833375
- Acronym / sponsor ID
- H00004724/H00015764
- Keywords
- TBI, stroke, ICH, AIS, decision aid, shared decision making, neurocritical care, SABI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Yale University, University of Florida, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 11 Feb 2018 (actual)
- Primary completion
- 2 Dec 2019 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 7 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and disability in adults in the U.S. Due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is the most common cause of death in SABI, but occurs at a highly variable rate (for example in Traumatic Brain Injury (TBI) 45-89%). Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. The investigators have developed a pilot DA for goals-of-care decisions for surrogates of SABI patients. This was developed through qualitative research using semi-structured interviews in surrogate decision makers of TBI patients and physicians. The investigators now propose to pilot-test a DA for surrogates of SABI patients in a feasibility trial.
Detailed description
Severe acute brain injury (SABI), including large artery acute ischemic stroke, intracerebral hemorrhage, and severe traumatic brain injury continue to be the leading cause of death and disability in adults in the U.S, accounting for more than 200,000 of the acute brain injury-related deaths in the U.S. annually. Patients with SABI are critically ill and most commonly require mechanical ventilation and supportive medical care with artificial nutrition to ensure survival. However, due to concerns for a poor long-term quality of life, withdrawal of mechanical ventilation and supportive medical care with transition to comfort care is by far the most common cause of death in SABI but occurs at a highly variable rate (for example in TBI 45-90%) at different trauma centers. Shared decision making is a collaborative process that enhances patients' and surrogates' understanding about prognosis, encourages them to actively weigh the risks and benefits of a treatment, and to match them to patient preferences, thereby decreasing decisional conflict and improving decision quality and health related outcomes. Decision aids (DAs) are shared decision-making tools which have been successfully implemented and validated for many other diseases to assist difficult decision making. No DA currently exists for goals-of-care decisions in SABI. Such a patient- and family-centered DA has the potential to improve decision-making for SABI patients by ensuring proxies receive consistent, evidence-based prognostication while also addressing patients' preferences and values. The investigators have developed a pilot DA for goals of care decisions by surrogates of SABI patients using qualitative research using semi-structured interviews in surrogate decision makers of TBI patients and physicians, followed by an iterative feedback process with feedback by surrogates, physicians, and other stakeholders (ICU nurses). The investigators now propose to pilot-test a DA for surrogates of SABI patients in a feasibility trial.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, usual-care-controlled feasibility trial comparing decision aid intervention prior to the goals-of-care family meeting to standard of care (no intervention prior to family meeting).
| Arm | Type | Receives |
|---|---|---|
| Usual Care (n=20) | No intervention | –Control: general information about TBI from Center for Disease Control (CDC)/about stroke/Intracerebral Hemorrhage (ICH) from American Heart/Stroke Association |
| Decision Aid (n=20) | Experimental | Other: Decision AidPaper Decision aid (share decision making tool) with worksheet for surrogates |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥18 years of age; no upper age limit
- Documented health care proxy or legal next of kin of admitted SABI patient with traumatic brain injury, intracerebral hemorrhage or acute ischemic stroke.
- ≥3 days after insult ("stabilization period"); clinical team may ask study team to wait longer if clinically indicated
- SABI patient remains "critically ill" after 3 days defined as: either intubated and mechanically ventilated, or unable to swallow, needing feeding tube beyond hospital discharge (even if not intubated)
- Surrogate is physically present in ICU to receive decision aid and participate in planned family meeting in person (not over phone)
Key exclusion criteria (4 listed)
- Devastating SABI near death
- Patient will be extubated and pass swallow evaluation (as deemed by clinical team)
- Surrogate is non-English speaking and no interpreter available to translate decision aid (no available validated, translated decision aid version)
- Surrogate is illiterate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision AidShared-decision making tool | Other | Decision Aid (n=20) |
Primary outcome
Recruitment
Time frame: From date of approaching surrogate decision maker for consent until the date of the first documented goals-of-care family meeting, assessed up to 1 month after admission.
Consent rate
Participation
Time frame: 1-36 hours after family meeting
Proportion of participants who read decision aid and completed worksheet
Retention
Time frame: 3 months
Number of participants who complete follow-up
14 secondary outcomes
Clinician-surrogate concordance scale score
Time frame: Baseline and 1-36 hours after family meeting
Decision Self-Efficacy Scale
Time frame: 1-36 hours after family meeting
Decisional Conflict Scale
Time frame: 1-36 hours after family meeting
AIS/Intracerebral Hemorrhage (ICH)/Traumatic Brain Injury (TBI) knowledge test
Time frame: Baseline and 1-36 hours after family meeting
Hospital Anxiety and Depression Scale (HADS)
Time frame: Baseline,1-36 hours after family meeting, and 3-months
Impact of Events Scale-revised
Time frame: Baseline,1-36 hours after family meeting, and 3-months
Quality of Communications Scale
Time frame: 1-36 hours after family meeting
Patient-Perceived Centeredness of Care Scale
Time frame: 1-36 hours after family meeting
Cumulative duration of the goals-of-care family meetings
Time frame: 1-36 hours after family meeting
Total number of goals-of-care family meetings
Time frame: 1-36 hours after family meeting
Patient's survival status
Time frame: 3-months after goals of care decision
Patient's Glasgow Outcome Scale
Time frame: 3-months after goals of care decision
Patient's modified Rankin Scale
Time frame: 3-months after goals of care decision
Surrogate Decision Regret Scale
Time frame: 3-months after goals of care decision
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Background: PubMed 28685395Quinn T, Moskowitz J, Khan MW, Shutter L, Goldberg R, Col N, Mazor KM, Muehlschlegel S. What Families Need and Physicians Deliver: Contrasting Communication Preferences Between Surrogate Decision-Makers and Physicians During Outcome Prognostication in Critically Ill TBI Patients. Neurocrit Care. 2017 Oct;27(2):154-162. doi: 10.1007/s12028-017-0427-2.
- Background: PubMed 30288437Moskowitz J, Quinn T, Khan MW, Shutter L, Goldberg R, Col N, Mazor KM, Muehlschlegel S. Should We Use the IMPACT-Model for the Outcome Prognostication of TBI Patients? A Qualitative Study Assessing Physicians' Perceptions. MDM Policy Pract. 2018 Mar 26;3(1):2381468318757987. doi: 10.1177/2381468318757987. eCollection 2018 Jan-Jun.
- Background: PubMed 25561435Muehlschlegel S, Shutter L, Col N, Goldberg R. Decision Aids and Shared Decision-Making in Neurocritical Care: An Unmet Need in Our NeuroICUs. Neurocrit Care. 2015 Aug;23(1):127-30. doi: 10.1007/s12028-014-0097-2.
- Background: PubMed 25990137Cai X, Robinson J, Muehlschlegel S, White DB, Holloway RG, Sheth KN, Fraenkel L, Hwang DY. Patient Preferences and Surrogate Decision Making in Neuroscience Intensive Care Units. Neurocrit Care. 2015 Aug;23(1):131-41. doi: 10.1007/s12028-015-0149-2.
- Derived from this study: PubMed 35853748Muehlschlegel S, Goostrey K, Flahive J, Zhang Q, Pach JJ, Hwang DY. Pilot Randomized Clinical Trial of a Goals-of-Care Decision Aid for Surrogates of Patients With Severe Acute Brain Injury. Neurology. 2022 Oct 3;99(14):e1446-e1455. doi: 10.1212/WNL.0000000000200937.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Susanne Muehlschlegel, MD, MPH principal investigator
University of Massachusetts, Worcester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision Aid in people with Traumatic Brain Injury and Ischemic Stroke, run by University of Massachusetts, Worcester at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: From date of approaching surrogate decision maker for consent until the date of the first documented goals-of-care family meeting, assessed up to 1 month after admission.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03833375, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.